The published literature for Oncotype primarily consists of validation studies to identify the optimal set of cancer-related genes. While there is important retrospective data, prospective studies(TAILRORX) are only now being done. Nevertheless, the test is recommended by several guidelines and is therefore medically necessary.
Oncotype is now widely accepted. The American Society of Clinical Oncology (ASCO) has included Oncotype DX™ into its 2007 updated clinical guidelines for the use of tumor markers in breast cancer. Most recently, NCCN has decided to include Oncotype in its 2008 guidelinesand BCBS issued a supportive TEC assessment. .
Based on several guidelines, I consider the evidence to show that Oncotype testing is medically necessary.
HER positivity is an independent poor risk factor that indicates adjuvant chemotherapy irrespective of Oncotype status. Oncotype has a much lower predictive values in such patients.
I. Baker J et al. Tumor gene expression predicts distant disease-free survival (DDFS) in breast cancer patients with 10 or more positive nodes: High throughput RT-PCR assay of paraffin-embedded tumor tissues. Proc Am Soc Clin Oncol 2003;22:850 (abstract 3415)
Paik S, Shak S, Tang G et al. Multi-gene RT-PCR assay for predicting recurrence in node negative breast cancer patients – National Surgical Adjuvant Breast and Bowel Project (NSABP) studies B-20 and B-14. San Antonio Breast Cancer Symposium. San Antonio, TX, December 2003. www.abstracts2view.com/bcs03/view.php?nu=BCS3L_701 (Verified 1/10/06)
Paik S, Shak S, Tang G, et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. NEJM 2004;351(27):2817-26
2007 TEC Assessment: Gene expression profiling for managing breast cancer treatment. www.bcbs.com/tec/vol20/20_03.html
National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Breast Cancer. http://nccn.org/professionals/physician_gls/PDF/breast.pdf
The American Society of Breast SurgeonsJuhi Asad et al Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer? The American Journal of Surgery (2008) 196, 527–529
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